(113 days)
The Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion appropriate for the size of the device. The screw is intended for single use only.
General trauma screw for compression and fixation of bone. The BioTy™ Nanotopography provides a microscopic roughened surface with nano-scaled features. The screws will be provided sterile in both solid and cannulated form, made of from titanium and stainless steel.
This document describes the regulatory submission for a medical device (bone screw) and does not contain information about Artificial Intelligence (AI) or machine learning (ML) device performance, acceptance criteria for AI/ML, or studies involving AI/ML.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for an AI/ML test set or data provenance.
- Number of experts used to establish ground truth for an AI/ML test set.
- Adjudication method for an AI/ML test set.
- MRMC comparative effectiveness study results for AI/ML.
- Standalone performance for an AI/ML algorithm.
- Type of ground truth used for an AI/ML device.
- Sample size for training set for an AI/ML device.
- How ground truth for an AI/ML training set was established.
The provided text pertains to a traditional 510(k) submission for a mechanical medical device (Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw). The acceptance criterion mentioned is for mechanical and material testing (Pull out Test per ASTM F543, Static Torsion Test per ASTM F543, and Pyrogenicity testing) and states that the device "met the acceptance criteria" for these physical tests. It explicitly states "Clinical Test Summary: n/a".
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.